Characterizing the management of hypocalcemia among European hemodialysis patients receiving cinacalcet (20150330)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23682
• EU PAS number:
  EUPAS17390
• Study ID:
  23682
• Official title and acronym:
  Characterizing the management of hypocalcemia among European hemodialysis patients receiving cinacalcet (20150330)
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  France

  Hungary

  Ireland

  Italy

  Poland

  Portugal

  Romania

  Russian Federation

  Serbia

  Slovakia

  Slovenia

  Spain

  Türkiye

  United Kingdom
• Study description:
  Hypocalcemia is a common adverse event in hemodialysis (HD) patients with secondary hyperparathyroidism (sHPT) receiving cinacalcet as first-line treatment. Patients using cinacalcet are six times more likely to experience hypocalcemia (total calcium <8.4 mg/dl) compared to those who do not use it. Any side effects such as hypocalcemia could adversely affect a patient’s level of medication compliance and/or adherence or changes in treatment strategies (e.g. dose reduction or discontinuation of cinacalcet). Calcium-containing phosphate binders, vitamin D sterols and/or adjustment of dialysis fluid calcium concentrations can be used to raise serum calcium according to clinical judgment. Dose reduction or cinacalcet discontinuation may negatively affect SHPT control. To date, treatment strategies to manage cinacalcet-induced hypocalcemia have not been well-characterized in a European HD population. In addition, it is unclear whether patients who recover from hypocalcemia will achieve adequate SHPT control. Data are needed to inform appropriate treatment guidance on the management of hypocalcemia among SHPT patients using cinacalcet.Therefore, we propose to characterize clinician treatment and management practices of hypocalcemia in a retrospective observational cohort study (Analysing Data, Recognizing Excellence and Optimising Outcomes Research initiative, AROii cohort) of incident European HD patients with sHPT who were prescribed cinacalcet.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Actual: 01/04/2016

Study start date

Planned: 30/01/2017

Actual: 30/01/2017

Data analysis start date

Planned: 01/02/2017

Actual: 24/04/2017

Date of final study report

Planned: 31/03/2018

Actual: 23/04/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol 20150330_2016-12-19

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable